Richard C. Dart, MD, PhD Denver Health & Hospital Authority Professor, University of Colorado School of Medicine

Transcription

1 Richard C. Dart, MD, PhD Denver Health & Hospital Authority Professor, University of Colorado School of Medicine

2 Goal: Minimize abuse and diversion (MAD) while providing pain control for patients. A claim of decreased abuse is difficult to study Behaviors to be measured are illegal, heavily stigmatized, and concealed. Use systems to measure when the subject is forced to expose themselves (the mosaic approach). Conclusions may vary depending on measure

3 Is the new drug abused? How does the abuse compare to other drugs? Importance of denominators Who abuses the product? How is the new product being abused? Ingestion, Inhalation (snorting), Injection, other Are there unintended victims? How will the information be applied? To assess abuse resistance/deterrence?

4 RADARS System Mosaic 300 rep 50 states 196 rep 46 states 49 PC 44 states 75 prog 33 states 400 rep 25 states Subset of systems 2000 rep 50 states Prescription Medication Issues Hidden events & motives Indications Formulations

5 85% Home 15% Health care All States Public Health Depts Chemical Mfrs Consumer Product Mfrs Pharmaceutical Mfrs Petroleum Industry Retail Industry Nationally Standardized Data Collection System 2.5 million exposures 2007

6 Triage and care advice , 24 x 7 x 365 National standards Certified staff Accredited centers Prehospital guidelines Board certified physician backup

7 All centers report data to National Poison Data System (NPDS) every 14 minutes Standardized data fields Explicit definitions Demographics Substance information Exposure information Clinical effects Therapy Outcomes NPDS FIELD NAMES NUMBER OF CHOICES Age Call Type & Call Type Subcategory Information Calls 120 Caller Site 9 Chronicity 4 Clinical Effects. 131 Duration of Effect 9 Exposure Duration 6 Exposure Site 9 Final HCF 12 Gender 4 Initial HCF 12 Level of HCF Care 6 Location Management Site 5 Medical Outcome 10 Override Pregnancy Duration Reason 19 Route 12 Scenario Category, Scenario ID 54 Species 2 Start Date State 60 Substance, Certainty 3 Substance, Formulation 7 Substance, Generic Substance, Product Specific Code Substance, Quantity Substance, Quantity Unit 17 Therapy 68 Weight Year

8 8 Smith MY, et al. Clinician validation of Poison Center (PCC) intentional exposure cases involving prescription opioids. Am J Drug Alcohol Abuse 2006;32:

9 Standardized data collection Health care professionals (RN, PharmD) National certification exam Entire US population has access Marketing to promote use Toll free number 24/7/365 Real time data collection Product specificity Geographic specificity (3DZ) Quality assurance Fields have rules

10 Spontaneous reporting PCs required to maintain call volume from all 3 DZ in their area Quality assurance Omissions Clinical judgments are recorded Case notes are not available

11 Can Poison Centers Detect Introduction of New Drug? Rate per 100,000 Population New Drug

12 Unlawful Narcotics Investigations, Treatment and Education

13 First activities early counties in Eastern Kentucky Methods Undercover narcotics investigations Treatment for substance abusers UNITE Provides support to families and friends of abusers Educates the public about the dangers of using drugs

14 Drug Roundups On April 6, 2004, Operation UNITE conducted a roundup of 210 suspected drug dealers in the eight county Kentucky River area the largest such operation in Kentucky s history. The sweep involved numerous city, county and state law enforcement agencies. Through December 30, 2008, there have been 120 roundups, with at least one in each of the 29 counties in the Fifth Congressional District.

15 Before UNITE After UNITE

16 Before UNITE After UNITE

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18 Yes, new product is abused Rate per 100,000 population Rate per 1000 URDD

19 How Does Abuse Compare to Other Opioids? Poison Center Intentional Exposures Rate per 100,000 population

20 How Does Abuse Compare to Other Opioids? Poison Center Intentional Exposures Rate per 1,000 URDD

21 , Intentional abuse: Intentional improper or incorrect use of a substance likely attempting to achieve a euphoric or psychotropic effect. All recreational use is included.

22 How Does Abuse Compare to Other Opioids? Associated Medical Outcome Percent of Intentional Exposures,

23 Many opioid medications are abused by a non oral route of administration Route of administration data is provided by four RADARS System programs Survey of Key Informant Patients (SKIP) College Student Survey Poison Centers Opioid Treatment Programs

24 New Drug

25 N Swallow % Chewed % Inhaled % Inject % Derm % New Drug Fentanyl Hydrocodone Hydromorph Methadone Morphine Oxycodone Stimulants Carisoprodol

26 1. Per caller: Person I know is crushing up New Drug, warming it in spoon and shooting up with it. He is acting really agitated, shaking and really hyperactive.. What should I do? 2. S; Dr want PC opinion y/o F took?? amts of fentanyl and morphine that was for son's PCA pump for pain (son has cancer) and injected self IV. EMS found unresponsive with resp 6, IV, naloxone admin, pt AAO x 3 on arrival

27 Caller: sister is a heroin addict and she is prescribed with generic hydrocodone/apap and she grabbed a tablet scraped it and added water and shoot it up. She is currently asx. caller wants to know what to do. ER: have adult female that scraped and injected a fentanyl patch. Unk concentration..came into ER lethargic and hypoventilating. Narcan and woke up. EMS call: medics on scene w/ 17 yo that supposedly injected XX oxycodone 3 4 hrs ago and has taken a few Oxycodone/Apap throughout the day. Currently awake and alert. Medics see some kind of trigeminy on the monitor. PCC rec transport.

28 Underrecognized Toll of Prescription Opioids in Children (Ann Emerg Med: Sept 2008) Any call for a child < 6 years and 1 opioid drug Buprenorphine Fentanyl Hydrocodone Hydromorphone Methadone Oxycodone Oxymorphone Tramadol

29 9,240 exposure mentions involving 9,179 children. National at least two fold higher Age range newborn to 5.5 years Ingestion (99%), unintentional (>99%) 92% occurred in the child s home (92%) 8 deaths National 2006 AAPCC data 9 of 29 (31%) deaths in child < 6 yrs 9 deaths were associated with an opioid drug

30 Surveillance must play a role in evaluating abuse deterrence/resistance. Some firm decisions or foundational concepts should be developed now. A claim for abuse resistance should be limited to a specific context. i.e. reducing experimental abuse in young adults Other surveillance systems should be developed to assess potential claims

31 We need to compare total abuse among drugs. Selection of comparator drug could depend on specific label. For example, if the abuse resistant drug is an controlled release product intended to treat chronic pain, it could be compared to OxyContin. Mosaic approach At least 3 populations should be included: Abusers, Children, Experimenters Comparison to at least two other drugs label and actual use Since time plays a role, needs to be ongoing.

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